TYLENOL PRECISE COOLING PAIN RELIEVING- lidocaine, menthol cream

Tylenol Precise Cooling Pain Relieving by

Drug Labeling and Warnings

Tylenol Precise Cooling Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine 4%............................................................................................... Topical analgesic

Menthol 1%.................................................................................................. Topical analgesic

Purpose

Topical analgesic

Uses

For the temporary relief of pain

Warnings

For external use only.

Do not use

▪ in large quantities, particularly over raw surfaces or blistered areas

When using this product

▪ avoid contact with eyes

Stop use and ask a doctor if

▪ condition worsens or symptoms persist for more than 7 days

▪ symptoms clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use only as directed
• adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

Other Information

store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)

Inactive Ingredients

carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water

Questions?

Call 1-877-895-3665 (toll-free) or 215- 273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 70g Tube in carton Label

Cooling †

Pain Relieving

Cream

Lidocaine 4% Menthol 1%

TYLENOL ®

PRECISE ®

Fast acting †

Powerful

targeted

pain relief

Maximum Strength

Lidocaine without a

prescription

LIGHTLY SCENTED

FOR

EXTERNAL

USE ONLY

NET WT 2.5 OZ (70 g)

INGREDIENTS AND APPEARANCE

TYLENOL PRECISE COOLING PAIN RELIEVING 
lidocaine, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0793
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
SORBITAN OLIVATE (UNII: MDL271E3GR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0793-1	1 in 1 CARTON	07/03/2023
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69968-0793-4	1 in 1 CARTON	07/03/2023
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69968-0793-9	2 in 1 CARTON	03/01/2024
3		113 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 69968-0793-2	1 in 1 CARTON	11/30/2025
4		70 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/03/2023

Labeler - Kenvue Brands LLC (118772437)